FDA Approves Multiple Submissions for SCANDONEST L Injection (Discontinued)

The FDA database lists SCANDONEST L as an injectable product (product number 001) with a dosage form of INJECTABLE. Its active ingredients are levonordefrin 0.05 mg/mL and mepivacaine hydrochloride 2%. The product’s marketing status is recorded as Discontinued. Since the original submission (ORIG 1, approved on 1984‑10‑10), SCANDONEST L has received numerous supplemental (SUPPL) submissions. These include labeling updates (e.g., submission numbers 5, 7, 8, 14, 15, 16, 19, 20, 27, 29, 30, 38) and manufacturing (CMC) submissions (e.g., numbers 5, 7, 15, 19, 20). All listed submissions have an approval status of "AP". The most recent approved supplemental submission is number 38 for labeling, dated 2018‑11‑02. Despite the series of approved filings, the product remains listed as discontinued, indicating it is no longer marketed in the United States.